By: Dr, Edit Goldberg
CEO

Escala Medical

Pelvic Organ Prolapse (POP) affects 1 in 3 women worldwide. Escala introduces the first incision-free repair solution for POP, to address an essential need that is estimated at over $1 billion in the growing women’s healthcare market.

$326,050

Raised so far

32

Investors

0

Days to go
Type: Convertible  
Stage: Seed +
Category: Healthcare
•  Overfunding - Over 100%    
  • Campaign Highlights
  • Pitch
  • Team
  • Investors 32
  • Updates

Campaign Highlights

Helping millions of women worldwide

As many as half of all women are affected by Pelvic Organ Prolpase; 30%-50% of women face POP during their lifetime. Moreover, the prevalence is expected to double in the next years due to the aging population. 
Escala’s repair system will change the way POP is treated today by shifting the point of care from the hospital to the doctor’s office, making it accessible to millions of women worldwide.
This shift aligns with the company’s goal to transform POP repair approach to dramatically improve outcomes and patient experience. 

 

A breakthrough repair alternative for an untapped patient population 

Currently, surgery is the only repair solution available for POP; yet, it is offered to fewer than 15% of patients. Today, women either compromise on their quality of life or wait until their condition deteriorates to a stage that requires surgery.
The incision-free, non-surgical solution by Escala, allows POP repair in an office setting.  
The breakthrough procedure can be performed in just 20 minutes. It provides a new treatment alternative that considerably reduces patient discomfort, recovery time and associated costs.

 

Invented by experts and backed by industry leaders 

Escala’s team combines proven leadership, innovation and experience in women’s healthcare. Founded in 2014, the company is led Dr. Edit Goldberg, an experienced executive in the medical device field with a diverse background in all stages of product development, from conception to commercialization. The medical advisors and inventors of the technology, Prof. Douglas Scherr and Dr. Roger Goldberg, are surgeons in leading US medical centers and are regarded as key opinion leaders in urology and urogynecology. Together, they have a history of successful developments and exits in this market. 
The board of directors includes senior management of The Trendlines Group, a leading early-stage investor in Israel that brings decades of entrepreneurial experience to Escala. 
Regarded as a promising company, Escala received over NIS 4 million in grants from the Israel Innovation Authority. 


Women’s health is a growing multi-billion dollar market 

More than 3,300,000 women are diagnosed with POP, with associated costs exceeding $1.4 billion annually in the United States alone. Current treatment alternatives are limited to supportive devices and surgery. The prevalence of POP is expected to double in the next years.
The market is dominated by large international medical device companies creating a competitive M&A landscape. Escala’s solution has already produced strong strategic interest as the total addressable market for the device is estimated in the billions of dollars. Escala is geared to success, looking to introduce the device into market in 2020. 

Pitch

The Idea

The Need

Currently, POP is repaired only with surgery. A non-surgical, incision-free alternative is not available


Pelvic Organ Prolapse (POP) is a painful, debilitating medical condition with a profound impact on the quality of life of many women. It occurs when the normal support of the vagina is lost, resulting in the “sagging” or dropping of the female pelvic organs. POP is a very common yet quite painful and bothersome condition affecting millions of women all over the world.

Though POP and its associated disorders are rarely life threatening, they have a direct and profound impact on quality of life (QOL).

Current treatment alternatives for women with POP are insufficient and limited. Supportive devices (pessaries) do not repair, and provide only a temporary solution. Repair surgeries are invasive and may be associated with short and long-term complications. Currently, there is no solution for women that had failed the supportive treatment, that are reluctant to undergo surgery or that poor surgical candidates. These women are forced to compromise on their quality of life as a non-surgical, repair treatment alternative is currently not available. 

Escala adresses that need with the first non-surgical, incision-free, repair device for Pelvic Organ Prolpase. 
  
 

 
The Idea

With Escala’s device POP can now be repaired in the doctor’s office 


The Escala device addresses a long, over-due need, offering a prolapse repair solution that can be performed as an office-based procedure rather than one requiring surgery. The Escala incision-free procedure does not require longer than 20 minutes to perform. As no cuts are involved the procedure may be performed at the doctor’s office.  
The Escala repair procedure is the first and only incision-free repair solution for prolapse. It restores anatomical positions and organ finctionality in three simple steps. 

 

The Technology

Escala’s 20 min. repair procedure represents a long over-due treatment for POP

The Escala repair device is a truly minimally-invasive system that is safer and easier to use compared to current solutions. The procedure is conducted with no incisions. The device combines an anchor, sutures, and a securing element delivered by a designated applicator. Unlike any other device, the Escala device may also be retrieved and removed during the procedure, further enhancing its safety. 
The Escala system comprises of well-defined materials, widely used in the medical device industry.  The production methods and processes are also common and no special processes are implemented in the manufacturing of the device. 

The device was extensively tested in animal trials and cadaver studies with 100% success and is protected by pending global and US patents. 

The Escala procedure is easy and quick to perform, and simplifies repair procedures requiring the highest degree of surgical skill. It eliminates the need for deep dissection and simplifies the repair procedure, thus minimizing associated short and long term complications.

IP

Protected technology 

Escala has two patent families. The patents, in national (USA, EU, China and Brazil) and PCT stages, strongly protect the device and protecting the technology as well as preventing others from performing an incision-free prolapse repair. 
The anchoring unit is the most significant component of the device. Successful prolapse repair is an outcome of sufficient resistance to pull out, as well as an accurate, trauma-free and safe delivery. The Escala umbrella-shaped anchor is the only one meeting all the clinical safety and performance requirements for the following reasons:  

Together with the designated applicator providing controlled and accurate delivery and retrieval, our device is the only system designed for a complete incision-free, optimal prolapse repair. 

The company’s IP was extensively evaluated by a leading IP firm as part of the due diligence conducted by Trendlines Medical prior to company establishment. In addition, the IP was evaluated by a larger international medical device company following which a term sheet for strategic investment was signed.


How does it work? 

Repair is achieved in a safe, three simple steps procedure usually taking no longer than 20 minutes to perform. Unlike other repair solutions, as no incisions are involved, the Escala device may be used both at the hospital and the doctor’s office. 


The Escala 20 min. repair procedure:

1. Position
The surgeon identifies a known landmark in the vagina by palpation and directs the tip of the applicator alongside his finger until it rests against the vaginal wall. 

2. Deploy
Squeezing the applicator’s trigger delivers the anchor through a needle in a very controlled manner and to a limited depth. Retracting the applicator leaves two sutures in the vagina.

3. Secure
a button-like securing element is threaded over the sutures and advanced all the way to the vaginal wall. The sutures are then tied and cut.  The procedure may be repeated twice on each side. 

The Market

The Business Model

Currently, POP is surgically repaired at the hospital, mostly in an outpatient setting. Escala will be the first to allow POP repair in an office based setting thus considerably reducing associated costs. The Escala device will be sold as a sterile, disposable kit for a single use. The end users are surgeons specializing in POP repair including urogynecologists, OBGYN and urologists. In the US, devices used during the repair procedure are covered by the reimbursement allowed amount of approximately $6000. These devices, including meshes and other anchor-based systems, are sold to hospitals by specialty distributors or medical device companies for $850 or higher. The Escala device will be sold for over $1000 per kit and distributed by specialty distributors and medical device companies specializing in women’s health. 

Escala’s business strategy comprises of two modular phases: generally, following regulatory approvals, the device will be commercialized via hybrid (direct + specialty distributors) or strategic partner distribution channels. Initially, the device will be sold to hospitals and medical centers treating POP patients, and will be covered by the existing reimbursement code. During this phase the company will conduct the clinical studies required to allow wide market penetration, and develop a reimbursement code for office-based procedures.  In the next phase, our device will be used to treat women with POP both in the outpatient and office-based settings.

Following regulatory approvals in the USA and EU the device will be made commercially available in 2020.

The Escala incision-free repair device is the only one addressing the needs of over 85% of the POP patients. As a comparison, the surgical repair devices address the needs of less than 15% of the patients. As such, Escala creates great interest among key players in this field including large, multinational medical device corporates. Following a long due diligence process a US-based medical device corporate has provided Escala a Letter of Intent for strategic partnership.
 

Funding To Date 

Escala enjoyed the support and funding of the Israel Innovation Authority (previously Israel’s Office of the Chief Scientist) to develop its innovative solution in two grants, recently receiving the third grant awarded to promising young companies. Among its investors are The Trendlines Group, a leading Israeli investor in early-stage medical devices technologies. Trendlines was the most active (by the number of investments) Israeli life science seed stage investor in 2016. Additional investors in Escala are the founders and angels from Israel and abroad.

How BIG is the OPPORTUNITY?

It is estimated that the lifetime prevalence for a woman with prolapse is between 30-50%. This means that 1 in 2 women that had given birth will have prolapse.
The global market  for  the  Escala  device  is  way  above  the  $1  billion  currently  estimated  for  surgical  devices representing approximately 15% of the POP patient population.  As the Escala device is the only one addressing the needs of all patients with POP, at various clinical stages, the market opportunity is estimated at billions of dollars. Moreover, the POP market is expected to double in the next years due to the aging population and increasing rates of obesity.
Looking at the USA figures: Over 3.3 million patients are diagnosed each year however approximately only 400,000 undergo surgical repair procedures. Hence, the need of nearly 3 million patients in the US alone is un-addressed. Currently, these women either compromise on their quality of life or wait until their condition deteriorates to a stage requiring surgery. Escala would present the only solution for those women, offering an office-based procedure that translates to a market opportunity of billions of dollars. In addition, reimbursement recently increased over 200% in favor of treatment in the office setting further supporting shift to this site of care.
The Escala system would be very profitable. Produced for less than $100 per device and with end user prices of products in the category as high as $1500, the gross profit margins for the Escala device are expected to be very high.

US market:


 
The Competitive Landscape 

Women with prolapse are typically elderly patients that suffer from other conditions preventing them from undergoing repair surgery for this debilitating condition. These women currently do not have any repair alternative that does not require incisions or the use of mesh.
The following diagram and table outline the differences between the treatment alternatives: 

o On the Surgical side, repair surgeries, including minimally invasive procedures and anchor-based surgical devices, may be associated with short- and long-term complications as well as great patient apprehension as with any surgery. 
Direct costs currently exceed $1.4B in the US alone. 

o On the non-surgical side, supportive devices (pessaries) do not repair prolapse, they provide only temporary relief of symptoms and are often associated with significant complications and discomfort. Hence, the compliance for their use is low. 
The Escala device is the only non-surgical, repair solution for POP. 

Escala’s device is superior to other anchor-based FDA approved products:

The Anchorsure (Neomedic, Spain) and Neuguide (POP Medical, Israel) devices are both surgical anchor-based devices.   that  demonstrate  well  the  feasibility  POP  repair  through  a  transvaginal approach.  However, both of these products require incisions in the vaginal wall, and hence cannot be used in the office setting. The Escala device uses a similar transvaginal approach, fixating the vagina to the ligament, only without requiring any incisions or cuts in the vaginal wall. Instead, the Escala device uses a “button-like” securing element that is expelled after several months when the sutures holding it in place have degraded.

Outcome impact of switching from existing solutions to the Escala device: 

• Office-based vs. hospital-based procedure will reduce the need for general anesthesia, recovery time and ultimately significantly reduce overall costs associated with the repair procedure.  Given that the procedure is incision free, pain (and concurrent analgesics) will be markedly reduced.  Further, given that the procedure is office based as opposed to hospital based, women are more likely to have the procedure done. 

Timeline

Escala addresses a valid clinical need in a large market with a short time to commercialization. 
Presented below is the company’s major events and milestones since establishment December 2014, with projected timeline and roadmap to commercialization in 2020. 

Exit Strategy

Exit strategy and Market Dynamics 

Global women’s health market has been growing at a phenomenal pace in the past few years. The global women’s health market was worth US$58.05 bn in 2016 and is expected to exhibit a CAGR of 5.7% until 2025.
Investors are increasingly interested in women’s healthcare ventures because these companies are reaching an underserved market with a huge demand and possibility of great financial return. 
The women’s health market is characterized by substantial activity of M&As with key players including international medical device corporates such as J&J, Medtronic, Boston Scientific and others. 
Based on the current expressed interest in Escala We estimate that in 3 years, the company will become a prime target for acquisition by a leading medical device. 
The projected sales volumes from commercialization in 3 years is expected to reach millions of dollars positioning Escala as an attractive M&A target. 

 

Use of Proceeds

Escala  was  established  December  2014.  Investments to  date  include  $1.1  million  by  the  Trendlines  Group,  the  Israel Authority of Innovation (IIA) and angel investors.

The funds raised will be used to accomplish two highly significant milestones – First in Human (FIH) clinical study and FDA
approval. Achieving those milestones is expected to double the company’s valuation in less than one year.

We believe in our ability to successfully and efficiently meet the milestones, and bring our device to the market in 2020.

Escala’s disruptive device is superior to existing solutions, and presents a long over-due treatment alternative to POP
that will restore quality of life to millions of women worldwide.

Team

Edit Goldberg, DMD, MBA
CEO
Biography
Over 15 years of medical device industry experience in senior development, strategic and business development positions.

Jonathan Schanin, MSc, MBA
CTO, Director
Biography
Senior corporate manager, vast experience in developing & marketing medical devices and pharmaceutical packaging. Technion graduate.

  • Director
Roger Goldberg, M.D., MPH
Founder, medical advisor, director
Biography
Clinical Associate Professor. Director, Division of Urogynecology. The University of Chicago Pritzker School of Medicine.

  • Founder
  • Director
  • Advisor
Douglas Scherr, M.D.
Founder, medical advisor, director
Biography
Professor of Urology. Clinical Director, Urologic Oncology, Weill Medical College of Cornell University.

  • Founder
  • Director
Julian Nikolchev
Director
Biography
Founder of several medical device start-ups, broad management experience in life sciences and medical device companies.

  • Director
Todd Dollinger
Director
Biography
Chairman and CEO, The Trendlines Group and Trendlines Medical.

  • Director
Nitza Kardish, Ph.D.
Director
Biography
CEO Trendlines Incubators, Vast experience in leading life science companies.

  • Director

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